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Minor surgical procedures and the outcome of immunotolerance induction: an analysis of the BrazIT Study

1Faculty of Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands, Belo Horizonte, Minas Gerais, Brazil, 2Faculty of Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil, 3Department of Clinics, Faculty of Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil, 4Faculty of Medicine, Universidade Federal de Minas Gerais, Brazil, Belo Horizonte, Minas Gerais, Brazil, 5Fundação HEMOMINAS, Belo Horizonte, Minas Gerais, Brazil, 6Centro de Hematologia e Hemoterapia do Ceará (HEMOCE), Fortaleza, Ceara, Brazil, 7Centro de Hematologia e Hemoterapia de Santa Catarina (HEMOSC), florianópolis, Santa Catarina, Brazil, 8Centro de Hematologia e Hemoterapia de Goiás (HEMOGO), Goiânia, Goias, Brazil, 9Fundação de Hematologia e Hemoterapia de Pernambuco (HEMOPE), Recife, Pernambuco, Brazil, 10Centro de Hematologia e Hemoterapia da Paraíba (HEMOÍBA), João Pessoa, Paraiba, Brazil, 11Centro de Hematologia e Hemoterapia do Piauí (HEMOPI), Teresina, Piaui, Brazil, 12Instituto de Hematologia do Estado do Rio de Janeiro (HEMORIO), Rio de Janeiro, Rio de Janeiro, Brazil, 13Hemocentro do Paraná (HEMEPAR), Curitiba, Parana, Brazil, 14Fundação HEMOPA, Belém, Para, Brazil, 15Centro de Hematologia e Hemoterapia do Rio Grande do Norte (HEMONORTE), Natal, Rio Grande do Norte, Brazil, 16Centro de Sangue de São José do Rio Preto, São José do Rio Preto, Sao Paulo, Brazil, 17Centro Regional de Hematologia e Hemoterapia de Londrina, Londrina, Parana, Brazil, 18Fundação Hemocentro de Rondônia (FHEMERON), Porto Velho, Rondonia, Brazil, 19Department of Pediatric Onco-hematology, Faculdade de Medicina de Marília, Marília, Sao Paulo, Brazil, 20Department of Internal Medicine, Faculty of Medicine, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, Belo Horizonte, Minas Gerais, Brazil

Abstract Number: PB0655

Meeting: ISTH 2022 Congress

Theme: Hemophilia and Rare Bleeding Disorders » Hemophilia - Clinical

Background: Inhibitors against factor VIII (FVIII) are associated with increased bleeding episodes, worse musculoskeletal outcomes, lower quality of life, and higher mortality in people with hemophilia A (PwHA). Immune tolerance induction (ITI) is the treatment of choice to eradicate inhibitors and recover the hemostatic activity of FVIII. Surgeries may induce immunological imbalances, perpetuating the stimuli to inhibitor maintenance.

Aims: Herein, we performed an analysis of the Brazilian Immunotolerance (BrazIT) Study to evaluate the impact of surgical procedures during ITI on its outcome.

Methods: PwHA on ITI (n = 207) were enrolled in 15 Brazilian hemophilia treatment centers. PwHA were treated according to the Brazilian ITI Protocol, which consists of starting with a low dose of FVIII (50 international units [IU]/kg 3x/week). High-dose ITI (100 IU/kg/day) was started if inhibitor titers did not reduce at least 20% of peak levels after 6 months. ITI outcomes were defined as (i) complete success: negative inhibitor titer ( < 0.6 BU/mL) and a normal FVIII pharmacokinetics (recovery ≥66% of expected values, and half-life ≥6 h) (ii) partial success: inhibitor titer ≤2 BU/mL and/or abnormal FVIII pharmacokinetics; and (iii) failure: success criteria was not achieved after 33 months of ITI. Clinical, laboratory, and therapeutic data were collected from medical files using a standardized form.

Results: A total of 161 (77.8%) of PwHA who completed ITI provided information on surgical procedures. The overall success rate of ITI was 68.9%. Forty-nine surgical procedures were reported for 31 (19.3%) PwHA during ITI. All the described procedures were minor surgeries. Central line insertion/removal was the most frequent (34.7%). The success rates were similar between PwHA who were submitted to surgeries during ITI (71.0%) and those who were not (68.5%; p >0.05).

Conclusion(s): We conclude that minor surgical procedures during ITI do not alter its outcome.

To cite this abstract in AMA style:

Camelo R, Moreira Dias M, de Magalhães L, Jardim L, De Oliveira A, Ribeiro R, Franco V, Roberti M, Callado F, Etto L, De Cerqueira M, Cerqueira M, Lorenzato C, Pinto I, Serafim É, Garcia A, Anegawa T, Neves D, Tan D, Rezende S. Minor surgical procedures and the outcome of immunotolerance induction: an analysis of the BrazIT Study [abstract]. https://abstracts.isth.org/abstract/minor-surgical-procedures-and-the-outcome-of-immunotolerance-induction-an-analysis-of-the-brazit-study/. Accessed September 27, 2023.

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